JP2005160600A - Liquid impregnating stent and liquid medication impregnating stent - Google Patents

Liquid impregnating stent and liquid medication impregnating stent Download PDF

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JP2005160600A
JP2005160600A JP2003401036A JP2003401036A JP2005160600A JP 2005160600 A JP2005160600 A JP 2005160600A JP 2003401036 A JP2003401036 A JP 2003401036A JP 2003401036 A JP2003401036 A JP 2003401036A JP 2005160600 A JP2005160600 A JP 2005160600A
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stent
impregnating
liquid
lumen
stenosis
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Daisuke Kawabe
大輔 河邊
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Ir:Kk
株式会社アイアール
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Abstract

<P>PROBLEM TO BE SOLVED: To provide a liquid impregnating stent easily impregnating a considerable amount of intended liquid medication and the like in a stent retaining a lumen by expanding a constriction in the lumen developed by various types of disease and suppressing a cause of the constriction in the lumen in an organism such as the blood vessel, the bile duct, the trachea, and the urethra. <P>SOLUTION: This liquid impregnating stent is formed of a porous metal material obtained by powder metallurgy and having multiple voids between particles and formed into an approximately cylindrical shape having pores in the circumferential wall. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

本願発明は、血管、胆管、気管、尿道等の生体内の管腔内において、各種の疾患により発生する管腔内狭窄を拡張して内腔を確保すると共に狭窄原因を抑制するための液含浸性ステント及び薬液含浸ステントに関する。 Invention is a blood vessel, bile duct, trachea, in the lumen of the body of the urethra, etc., the liquid impregnation for inhibiting stenosis causes while securing the lumen to expand the lumen stenosis caused by various diseases about sex stents and the chemical impregnated stent.

例えば、心臓の冠状動脈に生じた狭窄部を治療する方法として、バルーンを血管狭窄部に挿入して膨張させることにより狭窄部を拡張し、ついでバルーンを血管内から抜き出すPTCA法(経皮経管的冠動脈形成術)が広く行われたが、一時的に狭窄部を拡張しても、その後再狭窄が発生する事実が多くの症例にみられた。 For example, as a method for treating a stenosis occurring in coronary arteries of the heart, the balloon expands the stenosis by inflating and inserted into the blood vessel constriction, then PTCA method for extracting a balloon from the vessel (percutaneous coronary angioplasty), but is widespread, even temporarily expand the stenosis, the fact that subsequent restenosis occurs was observed in many cases.

上記の再狭窄を抑制するため、拡張した狭窄部にステンレス鋼線コイルからなる円筒状ステントを留置する方法が行われたが、ステントにより拡張保持されている血管内壁に内膜肥厚増殖が起きて再び狭窄を生じる場合が多かった。 To suppress the restenosis above, a method of placing a cylindrical stent made of stainless steel wire coil stenosis extended is performed, happening intimal hyperplasia proliferation vessel inner wall is expanded held by the stent in many cases, which again results in a constriction.

そこで、従来、アンギオペプチン、カプトプリル等の抗増殖剤を添加したポリグリコール酸、ポリウレタン、ポリエチレン等のポリマー溶液を、ステントを構成するステンレス鋼線の表面に噴霧、浸漬等によりコーティングしたもので、該ステントを血管狭窄部に拡張留置することで抗増殖剤を狭窄部内壁面に放出させるものが提案された。 Therefore, conventionally, angiopeptin, polyglycolic acid added antiproliferative agents such as captopril, polyurethane, a polymer solution, such as polyethylene, sprayed onto the surface of the stainless steel wire constituting the stent, which was coated by immersion or the like, which emit an antiproliferative agent stenosis inner wall surface by extending indwelling the stent in the vascular stenosis portion has been proposed.

しかし、上記の薬剤コーティングステントでは、コーティング膜が極薄のため、挿入時にコーティング膜が剥落するおそれがあり、又薬剤の含有量が少いばかりでなく、薬剤の放出が十分に行われないため、所期の薬剤効果を達成できない欠点があり、しかもステントに薬剤を補充することができない経済的不利益もあった。 However, in the above drug-coated stents, since the coating film is extremely thin, there is a risk of spalling coating film during insertion, addition not only a small content of a drug, for release of the drug is not sufficiently performed has the disadvantage that can not achieve the intended drug effects, yet was also economic disadvantages unable to replenish the drug to the stent.
特開2003−33439 JP 2003-33439

本願第1発明は、所望の薬液等を相当量容易に含浸させることができる液含浸性ステントを提供し、本願第2発明は、薬液を十分放出すると共に管腔内に留置したままで必要薬液を補充することができる薬液含浸ステントを提供する。 First invention provides a liquid impregnating stents can be significant amounts readily impregnate the desired drug solutions or the like, the present second invention, necessary chemical remain indwelling in the lumen with sufficient release the chemical providing a chemical impregnated stent can be replenished.

そこで、本願第1発明は、 Therefore, the present first invention,
粉末冶金法により得られる、粒子間に多数空隙を有する多孔質金属材料からなり、周壁に細孔を有するほぼ円筒状に形成された、 By powder metallurgy obtained, a porous metal material having a large number voids between the particles, is formed in a substantially cylindrical shape having pores in the peripheral wall,
液含浸性ステントを提案し、 It proposed a liquid-impregnated stent,
本願第2発明は、 The present second invention,
上記第1発明のステントの多数空隙内に所要の薬液を含浸させた、薬液含浸ステントを提案する。 Impregnated with a desired liquid medicine to a number in the gap of the stent of the first invention proposes a chemical impregnated stent.

本願第1発明の液含浸性ステントによれば、所望の薬液を容易に含浸させることができると共に、従来ステントよりも多量の薬液を含浸させることができるのである。 According to the liquid impregnation stent of the first feature of the present invention, it is possible to easily impregnate the desired chemical, it is possible to impregnate a large amount of liquid medicine than conventional stents.

また、本願第2発明の薬液含浸ステントによれば、これを管腔内に挿入する際薬液をほとんど失うことなく所定位置まで挿入することができると共に、所定位置で薬液を継続的且つ円滑に放出し、所期の薬液効果を果すことができ、しかも薬液が使用しつくされた後、ステントを所定位置に留置したままで新たに薬液を補充することができる利点もえられるのである。 Further, according to the chemical impregnating the stent of the present second invention, which together with the chemical liquid upon insertion into a lumen may be inserted to a predetermined position without losing almost continuously and smoothly the chemical in place release and, it is possible to perform the desired chemical effect, yet after the chemical has been used up, it is the also e advantage that can be newly replenished chemical liquid while stenting place.

本発明における上記「ステント」は、ステンレス鋼、ニッケル−チタン合金、チタン−アルミニウム合金、形状記憶合金、ロジウム、タンタル等の弾性材又は塑性材からなり、その形状は、円筒状コイル、ネットからなる円筒等のほぼ円筒状体で、その周壁に多数又は少数の細孔を設けたものである。 The "stent" in the present invention include stainless steel, nickel - titanium alloys, titanium - made of aluminum alloy, shape memory alloys, rhodium, elastic material or plastic material such as tantalum, its shape is cylindrical coil, consisting of a net in generally cylindrical body such as a cylinder, it is provided with a large number or a small number of pores in its wall.

また、上記「薬液」には、血管等の内膜肥厚増殖抑制剤として、ラパマイシン、タキソール等、その他種々のものの溶液、抗ガン剤として、タキソール、タキソテール、トポテシン等のアルカロイド類、アドレアシン、ブレオ等の抗生物質、その他種々のものの溶液、抗血栓剤として、ヘパリン、ヒルジン、アルガトロバン、等その他種々のものの溶液がある。 Further, the "chemical" as intimal thickening growth inhibitor such as a blood vessel, rapamycin, taxol etc., other various types of solutions, as an anticancer agent, taxol, taxotere, alkaloids such as Topotecin, Adoreashin, Bureo etc. antibiotics, other solutions of various things, as antithrombotic agents, heparin, hirudin, argatroban, a solution of equal other various things. このほか狭窄の病因を治療する各種の薬液が使用される。 Various chemicals to treat the etiology of the other stenosis is used.

本例は、冠状動脈のタテロームによる狭窄部に使用される液含浸性ステントで、316Lステンレス鋼を用いて粉末冶金法により得られた、粒子間に多数の空隙を有する多孔質弾性材をもって形成されたネット状円筒体である。 This example is a liquid impregnating stents used for stenosis due Tateromu coronary using 316L stainless steel obtained by powder metallurgy, is formed with a porous elastic material having many voids between the particles It was a net-like cylindrical body.

上記狭窄部の拡張施術に先だち、上例の液含浸性弾性ステントを内膜肥厚増殖抑制剤「ラパマイシン」の溶液中に所要時間浸漬し、それにより上記ステントの多数空隙内にラパマイシン溶液を十分に含浸させる。 Prior to expansion treatment of the stenosis, and the required time immersed in a solution of a liquid impregnation elastic stents in the above example intimal hyperplasia proliferation inhibitor "a rapamycin", thereby rapamycin solution thoroughly in numerous voids of the stent impregnated.

上記のラパマイシン含浸弾性ステントを小径に圧縮した状態でカテーテル内に収納し、該カテーテルを冠状動脈内の狭窄部まで挿入し、そこで上記弾性ステントをカテーテル内から狭窄部内に押し出し、その押し出しにより該弾性ステントを弾性復元力により元の大径円筒形に拡径させ、それにより該拡径弾性ステントにより狭窄部を拡張し、その状態で拡張狭窄部の内周面に圧接留置する。 Housed in a catheter in a compressed state above rapamycin impregnated elastic stent diameter, the catheter is inserted to the stenosis in the coronary arteries, where extruded into the stenosis the elastic stent from the catheter, elastic by its extrusion the stent is expanded to the original large-diameter cylindrical shape by an elastic restoring force, thereby expanding the narrowed portion by the enlarged 径弾 stents, pressure contact placed on the inner peripheral surface of the expansion constriction in this state.

上記のように留置されたラパマイシン含浸ステントは、その空隙内に保有するラパマイシン溶液を徐々に放出して血管内膜に供給し、その肥厚増殖を抑制し、その再狭窄を防止する。 Indwelling rapamycin impregnated stent as described above, the rapamycin solution held in the gap gradually releasing supplied to intimal suppresses the thickening growth, prevents the restenosis.

ステントに含有される薬液が放出しつくされたときは、該ステントを血管内に留置したまま、該ステントを血流から遮へいし、その状態で新たなラパマイシン溶液をステントに噴射してその空隙内に吸収させる。 When the chemical solution contained in the stent has been exhausted release while indwelling the stent in a blood vessel, the stent is shielded from the blood flow, the air gap by injecting new rapamycin solution in that state to the stent to be absorbed in. これを繰り返して長時間の狭窄部拡開を継続する。 To continue for a long period of time stenosis expanded by repeating this.

本例は、胆管のガンによる狭窄部に使用される液含浸性ステントで、タンタルを用いて粉末冶金法により得られた、粒子間に多数の空隙を有する多孔質塑性材をもって形成されたネット状円筒体である。 This example is a liquid impregnating stents used for stenosis due to cancer of the bile duct, obtained by powder metallurgy method using tantalum, net-like, which is formed with a porous plastic material having many voids between the particles it is a cylindrical body.

上記狭窄部の拡張施術に先だち、上例の液含浸性塑性ステントを抗ガン剤「タキソール」溶液中に所要時間浸漬し、それにより上記ステントの多数空隙内にタキソール溶液を十分に含浸させる。 Prior to expansion treatment of the stenosis, the liquid impregnation property plastic stent in the above example and required time immersed in the anticancer agent "Taxol" solution, thereby sufficiently impregnating the taxol solution in many of the stent gaps.

上記のタキソール含浸塑性ステントを小径に縮小した状態で、収縮したバルーンの表面に装着し、該バルーン及びステントをカテーテル内に収納して胆管の狭窄部まで挿入し、そこでバルーン及びステントをカテーテル内から狭窄部内に押し出し、ついでバルーンを膨張させ、それにより塑性ステントを大径の円筒形に塑性変形させて狭窄部を拡張すると共に、該ステントを拡張狭窄部内周面に圧接留置させる。 While reducing the taxol-impregnated plastic stent diameter, was mounted on the surface of the deflated balloon, the balloon and the stent are accommodated within a catheter inserted to the stenosis bile duct, where the balloon and stent from the catheter extruded into the stenosis and then is inflated the balloon, thereby together with the plastic stent is plastically deformed to a larger diameter cylindrical expanding the stenosis, it is pressed against indwelling the stent expanded stenosis inner peripheral surface.

上記の留置されたタキソール含浸ステントは、その保有するタキソール溶液を徐々に放出して胆管狭窄部のガン細胞に供給し、その細胞増殖を抑制する。 The above indwelling taxol impregnated stent, gradually releasing taxol solution it holds is supplied to the cancer cells of biliary stricture, inhibiting their proliferation.

タキソール溶液のステントへの補充は、胆管を一時的に遮断した状態で新たなタキソール溶液をステントに放射して吸収させる。 Recruitment to the stent taxol solution, a new taxol solution is absorbed by radiation to the stent in a state of temporarily blocking the bile duct.

Claims (2)

  1. 粉末冶金法により得られる、粒子間に多数空隙を有する多孔質金属材料からなり、周壁に細孔を有するほぼ円筒状に形成された、 By powder metallurgy obtained, a porous metal material having a large number voids between the particles, is formed in a substantially cylindrical shape having pores in the peripheral wall,
    液含浸性ステント。 Liquid impregnated stents.
  2. 請求項1のステントの多数空隙内に所要の薬液を含浸させた、薬液含浸ステント。 Numerous claim 1 stent impregnated with the required chemical solution into the gap, chemical impregnated stent.



JP2003401036A 2003-12-01 2003-12-01 Liquid impregnating stent and liquid medication impregnating stent Pending JP2005160600A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7833266B2 (en) 2007-11-28 2010-11-16 Boston Scientific Scimed, Inc. Bifurcated stent with drug wells for specific ostial, carina, and side branch treatment
US7951193B2 (en) 2008-07-23 2011-05-31 Boston Scientific Scimed, Inc. Drug-eluting stent
JP2016516780A (en) * 2013-04-10 2016-06-09 マサチューセッツ インスチテュート オブ テクノロジーMassachusetts Institute Of Technology Drug local delivery devices and methods for the treatment of cancer

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7833266B2 (en) 2007-11-28 2010-11-16 Boston Scientific Scimed, Inc. Bifurcated stent with drug wells for specific ostial, carina, and side branch treatment
US7951193B2 (en) 2008-07-23 2011-05-31 Boston Scientific Scimed, Inc. Drug-eluting stent
JP2016516780A (en) * 2013-04-10 2016-06-09 マサチューセッツ インスチテュート オブ テクノロジーMassachusetts Institute Of Technology Drug local delivery devices and methods for the treatment of cancer

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